What is NDC 80425-0035?

80425-0035 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gabapentin?

561 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gabapentin NDC 80425-0035 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0035Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80425-0035-1	8042500350180425003501	30 TABLET in 1 BOTTLE (80425-0035-1)Marketed from Nov 1, 2015

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Gabapentin
Generic name (nonproprietary): gabapentin
Active ingredients: Gabapentin — 800 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206402
Marketing start: Nov 1, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 80425-0035_2a984dd9-729b-77f0-e063-6294a90a8f1eSPL ID 2a984dd9-729b-77f0-e063-6294a90a8f1eSPL set ID afa28969-91ca-83fd-e053-2a95a90a656bRxCUI 310434UNII 6CW7F3G59X

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425003501 followed by a unit qualifier and the quantity

Package 80425-0035-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 31, 2024.

Indications (excerpt from the label)

Indications and Usage Section Gabapentin is indicated for: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0035

What is NDC 80425-0035?: 80425-0035 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gabapentin.
What is the active ingredient?: Gabapentin.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gabapentin?: 561 other product NDCs are listed under this name. See all Gabapentin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Gabapentin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gabapentin	Gabapentin 800 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-943	60760-0943-3060760-0943-90
gabapentin	Gabapentin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4763	70518-4763-00
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0581	55154-0581-00
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0595	80425-0595-0180425-0595-0280425-0595-03+1 more
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4746	70518-4746-0070518-4746-0170518-4746-02+1 more
Gabapentin	Gabapentin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4742	70518-4742-0070518-4742-02
Gabapentin	Gabapentin 400 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4740	70518-4740-0070518-4740-01
Gabapentin	Gabapentin 300 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0580	55154-0580-00
Gabapentin	Gabapentin 600 mg/1	Tablet, CoatedOral	Coupler LLC	67046-1233	67046-1233-03
Gabapentin	Gabapentin 200 mg/1	CapsuleOral	Trifluent Pharma, LLC	73352-231	73352-0231-01

All 562 Gabapentin NDCs

Other NDCs under ANDA 206402

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206402
Product	Strength	Form · route	Labeler	Product NDC
Gabapentin	Gabapentin 600 mg/1	TabletOral	Ascend Laboratories, LLC	67877-428
Gabapentin	Gabapentin 800 mg/1	TabletOral	Ascend Laboratories, LLC	67877-429
Gabapentin	Gabapentin 800 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-5310
Gabapentin	Gabapentin 600 mg/1	TabletOral	REMEDYREPACK INC.	70518-2842
Gabapentin	Gabapentin 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-2912
Gabapentin	Gabapentin 600 mg/1	TabletOral	Bryant Ranch Prepack	71335-1200
Gabapentin	Gabapentin 800 mg/1	TabletOral	Bryant Ranch Prepack	71335-2037
Gabapentin	Gabapentin 800 mg/1	TabletOral	Bryant Ranch Prepack	71335-2038
Gabapentin	Gabapentin 600 mg/1	TabletOral	Bryant Ranch Prepack	71335-2048
Gabapentin	Gabapentin 600 mg/1	TabletOral	Bryant Ranch Prepack	71335-2281
Gabapentin	Gabapentin 800 mg/1	TabletOral	Direct_Rx	72189-619